Hypodermic syringe with vial attachments

ABSTRACT

A medical syringe apparatus includes a syringe unit, a hypodermic needle attached to the syringe unit and at least one interfacing member for mating a labeled medication container to the syringe unit. A filling needle is attached to the syringe unit for drawing fluid from a container. A movable needle sheath protects the hypodermic needle when not in use and may be moved out of the way when administering an injection. The medication label is visible. The container remains mated to the syringe when the syringe is in use. Risk of mislabeling the syringe may therefore be substantially reduced or eliminated and patient safety may accordingly be improved.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a division of U.S. patent application Ser. No.12/055,075, filed on Mar. 25, 2008, and entitled “Hypodermic Syringewith Vial Attachment,” now U.S. Pat. No. 9,901,682 issued on Feb. 27,2018, and which claims the benefit of provisional application Ser. No.60/911,634, filed Apr. 13, 2007, the disclosures of which areincorporated by reference herein.

BACKGROUND OF THE INVENTION 1. Technical Field

The present disclosure relates to hypodermic syringes and, morespecifically, to hypodermic syringes with vial attachment(s) that allowfor automatic and correct labeling of the syringes.

2. Discussion of the Related Art

In the course of administering medication to a patient by hypodermicinjection, a syringe is filled from a vial of medication. While the vialis pre-labeled according to its contents, the syringe is generallyunlabeled when removed from sterile wrapping. Medical practitioners suchas physicians, nurses and medical technicians, may take the time tomanually label a syringe after drawing medication from a vial. A syringethat is so-labeled reduces the chance of administering an incorrectmedication, an occurrence that is commonly known as ampule swap error orsyringe swap error.

Syringe swap error may be a particular risk in the field ofanesthesiology where multiple different medications are used and aparticular medication may be called upon at a moment's notice. Forexample, some medications must be administered in rapid succession.

Multiple medications may be drawn up in multiple syringes and labeled inthe course of preparing for a surgical case, however this process may betime consuming and may itself be prone to error. In the real-worldsetting, medical practitioners may be unwilling and/or unable to takethe time to properly label each syringe. Moreover, in manually labelingeach syringe, labeling errors may occur, especially where labels arewritten hastily. Additionally, manually labeled syringes may not bereadily legible.

Since over 5 billion injections will be given each year in the UnitedStates and practitioners can make mistakes such as mislabeling syringesduring a certain fraction of those injections, the potential forcomplications related to syringe mislabeling is large. For example, itis estimated that there is some type of medication administration errorfor every 130 anesthetics administered. Moreover, it is highly likelythat medication errors are underreported.

Manual labeling may give rise to other potential problems, for example,the type of medication may be labeled but other information such as theconcentration, the inactive ingredients, and the expiration date may beomitted. Such information may even be intentionally omitted from thesyringe labels but may later be needed in order to quickly determine thecause of a problem in the event of complications, at which point, thevial may have since been deposited in a sharps container and may beirretrievable.

Labels may be preprinted in an attempt to minimize some of the problemsdiscussed above; however, preprinted labels may be mistakenly applied tothe wrong syringe. Moreover, the use of adhesive labels may beproblematic when working with gloved hands, as is generally the case inoperating rooms.

Syringes may be pre-labeled at the time of assembly; however,pre-labeled syringes are significantly less versatile as a syringepre-labeled for one medication may not be used to administer anothermedication. Accordingly, hospitals and other medical facilities muststock enough syringes for each type of medication used. Accordingly, thecosts of procuring, storing and retrieving the correct pre-labeledsyringe may be inordinately expensive. Moreover, the incorrectpre-labeled syringe may be inadvertently used.

Labeled syringes can be pre-filled with medication at the factory. Suchpre-filled syringes are available for some medications, but arecumbersome in that they need to be assembled with special injectorsprior to use. This re-assembly adds time to procedure setup. Inaddition, drugs packaged this way are more expensive to produce andrequire more storage space than drugs packaged in traditional vials andampules. For this reason the cheaper and more space efficient vials andampules continue to be used in most hospitals.

Significant advances have been made in industrial quality control whenit comes to labeling medications at the factories where they areproduced. Although each year, billions of medication vials, ampules andbottles are produced, there are no recalls issued for inaccurate orincomplete labeling. Separation of assembly lines, chemical analyses andother quality control measures have reduced the possibility of amiss-labeled medication container.

However, when a disposable syringe is used to draw up and administer amedication in clinical practice, labeling the syringe depends onthoughtful input from a medical practitioner such as a physician ornurse.

SUMMARY

Embodiments of the present invention provide a syringe that can bereliably labeled each time a medication is transferred to the syringe sothat contents of the syringe can be correctly labeled, essentiallyindependent of or independent of practitioner thought or attention.

A medical syringe apparatus includes a syringe unit. A filling needle isattached to the syringe unit for drawing fluid from a container. Ahypodermic needle is attached to the syringe unit for injecting thefluid drawn from the container. The filling needle and the hypodermicneedle are two distinct needles.

A medical syringe apparatus includes a syringe unit. A hypodermic needleis attached to the syringe unit for injecting the fluid drawn into thesyringe unit. A needle sheath protects the hypodermic needle. The needlesheath is rotatably connected to the syringe unit such that the needlesheath reveals the hypodermic needle when force is provided and concealsthe hypodermic needle when force is discontinued.

A method for administering a hypodermic injection includes applyingforce to a needle sheath to move the needle sheath and reveal ahypodermic needle. The hypodermic injection is administered while theneedle sheath is in the moved position. Force is discontinued to returnthe needle sheath to its original position and to conceal the hypodermicneedle.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the present disclosure and many of theattendant advantages thereof will be readily obtained as the samebecomes better understood by reference to the following detaileddescription when considered in connection with the accompanyingdrawings, wherein:

FIG. 1 illustrates a syringe capable of mating with a medicine containeraccording to an exemplary embodiment of the present invention;

FIG. 2 illustrates a syringe having multiple interfacing members formating with medicine containers of various sizes according to anexemplary embodiment of the present invention;

FIG. 3 illustrates a syringe capable of mating with a medicinecontainer, for example, an ampule 30 with a sharp end, while protectingthe medical practitioner from risk of accidental contact with the sharpend, according to an exemplary embodiment of the present invention;

FIG. 4 illustrates a syringe including an adhesive cup as an interfacingmember according to an exemplary embodiment of the present invention;

FIG. 5 illustrates a syringe capable of mating with a medicine containeraccording to an exemplary embodiment of the present invention;

FIG. 6 illustrates a syringe attached to a vial via a locking memberaccording to an exemplary embodiment of the present invention;

FIG. 7 illustrates a tether connecting a syringe with a containeraccording to an exemplary embodiment of the present invention;

FIG. 8 illustrates a syringe including multiple interfacing membersaccording to an exemplary embodiment of the present invention;

FIG. 9 illustrates a syringe with integrated interfacing membersaccording to an exemplary embodiment of the present invention;

FIG. 10 illustrates a syringe including an interfacing member for matinga container of medication where the interfacing member includes amagnifying member for magnifying a label of the container of medicationaccording to an exemplary embodiment of the present invention;

FIG. 11A illustrates a method for labeling a syringe according to anexemplary embodiment of the present invention;

FIG. 11B illustrates another method for labeling a syringe according toan exemplary embodiment of the present invention;

FIG. 11C illustrates another method for labeling a syringe according toan exemplary embodiment of the present invention;

FIG. 12 is a schematic illustrating a syringe capable of mating with amedicine container and drawing medication from the container while in amated state according to an exemplary embodiment of the presentinvention;

FIG. 13 is a schematic illustrating a syringe capable of mating with acontainer and drawing medication from the container while in a matedstate according to an exemplary embodiment of the present invention;

FIG. 14 is a schematic illustrating a syringe capable of mating with amedicine container and drawing medication from the container while in amated state according to an exemplary embodiment of the presentinvention;

FIG. 15 is a schematic illustrating a spring-loaded needle sheathaccording to an exemplary embodiment of the present invention;

FIG. 16 is a flow chart illustrating a method for administering ahypodermic injection according to an exemplary embodiment of the presentinvention;

FIGS. 17a and 17b are schematics illustrating a luer tip syringe with aprotective cap according to an exemplary embodiment of the presentinvention;

FIG. 18 is a syringe and penetration spike according to an exemplaryembodiment of the present invention; and

FIG. 19 is a schematic diagrams illustrating a syringe and penetrationspike apparatus according to an exemplary embodiment of the presentinvention;

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

In describing the exemplary embodiments of the present disclosureillustrated in the drawings, specific terminology is employed for sakeof clarity. However, the present disclosure is not intended to belimited to the specific terminology so selected, and it is to beunderstood that each specific element includes all technical equivalentswhich operate in a similar manner.

Exemplary embodiments of the present invention relate to a syringe, forexample, a hypodermic syringe, which may be mated to a medicationcontainer, for example, an ampule or vial. After drawing medication fromthe vial into the syringe, the medical practitioner may mate the usedvial to the syringe. By mating the medication vial to the syringe,medical practitioners may be able to easily determine the contents ofthe syringe by reading the label on the medication vial.

According to some exemplary embodiments of the present invention, thevial may be mated to the syringe by an interfacing member incorporatedwith the syringe. The interfacing member may lock the vial in placeusing friction forces and/or an adhesive coating. The interfacing membermay be able to accommodate vials of various body and neck sizes byflexing, bending and/or choking down on the vial. In some exemplaryembodiments, the vial may be permanently affixed to the syringe. Inother exemplary embodiments, the vial may be removably affixed to thesyringe, for example, to allow for additional medication to be drawnfrom the vial at a latter point and to allow for subsequent reattachmentof the vial to the syringe. Where the vial is removably affixed, atethering connector may be used to ensure physical proximity and tominimize the risk of the wrong vial being affixed to the syringe.

A user, for example a medical practitioner, may mate the vial to thesyringe after drawing medication from the vial into the syringe. Afterthe medication has been drawn, the user may be holding the syringe inone hand and the vial in the other hand. Accordingly, the vial may bequickly and easily mated to the interfacing member of the syringe afterthe medication has been drawn. Where multiple syringes are used to drawmedication from multiple corresponding vials, the user may easily drawmedication and mate the corresponding vial to the syringe before thesyringe and vial are put down. Accordingly, multiple medications may bedrawn into multiple corresponding syringes and the syringes may belabeled by mating the corresponding vial to the corresponding syringewith little to no risk of label confusion.

Exemplary embodiments of the present invention contemplate variousinterfacing members including snapping locks, clamping locks, tyinglocks, ratchet locks, twist locks, buckle locks, adhesive pads, and thelike. According to some exemplary embodiments, a single syringe mayinclude multiple interfacing members for holding multiple vialssimultaneously, where a single syringe contains multiple medications.Alternatively, the multiple interfacing members may be used to hold asingle vial and the multiple interfacing members are each suitable formating a vial of a different size and/or shape.

The figures and the disclosure below describe various exemplaryembodiments of the present invention having various features. It shouldbe understood that the features described with respect to one exemplaryembodiment may be combined with features described with respect to otherexemplary embodiments.

FIG. 1 illustrates a syringe capable of mating with a medicine containeraccording to an exemplary embodiment of the present invention. In FIG.1, the syringe 10 may have an interfacing member for mating a medicationvial 14 to the syringe 10. The interfacing member may be, for example, aclamping unit 12. The clamping unit 12 may include a material that canflex and exert a restoring force, for example, a plastic or a shapememory alloy. Accordingly, a portion of the vial 14, for example a cap16 of the vial 14, may be inserted into the clamping unit 12 and may beheld in place by friction forces. The clamping unit 12 may be arrangedto allow for the vial 14 cap 16 to be inserted and to prevent easyremoval. This may be accomplished, for example, by including a pluralityof flexors that are bent inwards, as shown. Alternatively, theinterfacing member may be a clamping unit 18 including a plurality offlexors that are not bent inwards so that insertion, removal andreinsertion may be more easily accommodated.

In some exemplary embodiments of the present invention, a tether 20 isprovided to link the syringe 10 to the vial 14, even when the vial 14 isnot mated. The tether 20 may be a flexible material such as plastic,latex, string, wire or the like. The tether 20 may attach to the vialby, for example, an adhesive measure or by friction. For example, thetether 20 may have a rubber band loop for holding the vial 14.Alternatively, the tether 20 may include a plastic tie-wrap, also knownas a zip tie, for holding the vial 14. The tether 20 may secure the vialat its body, as shown, or the tether 20 may secure the vial at its neck.

Alternatively, the vial 14 may be glued, taped, snapped or screwed tothe syringe 10. In such exemplary embodiments, the interfacing membermay be the selected adhesive mechanism. The interfacing member may beattached to the syringe 10 during manufacture; alternatively, theinterfacing member may be formed as part of the syringe 10, for example,during an injection molding process, extrusion process or some othermanufacturing process.

According to an exemplary embodiment of the present invention, theinterfacing member may be an adhesive pad attached to the syringe 10.The adhesive can be on the body or plunger of the syringe itself and/orcovering an adhesive cup. The adhesive pad may be covered with aprotective film that may be easily removed when coupling to a vial isdesired.

As discussed above, exemplary embodiments of the present invention mayhave multiple interfacing members for mating either multiple medicationcontainers at the same time or for mating one of a variety ofdifferently sized containers. FIG. 2 illustrates a syringe havingmultiple interfacing members for mating with medicine containers ofvarious sizes according to an exemplary embodiment of the presentinvention. In FIG. 2, the syringe 10 includes a first interfacing member22 and a second interfacing member 24. While some exemplary embodimentsof the present invention may have multiple interfacing members of thesame size, FIG. 2 shows an exemplary embodiment having multipleinterfacing members of differing sizes. While some exemplary embodimentsmay have one, two, three or more interfacing members, FIG. 2 shows anexemplary embodiment having two interfacing members.

The first interfacing member 22 may be a small-sized interfacing memberfor mating to small ampules or vials. The second interfacing member 24may be a large-sized interfacing member for mating to large ampules orvials. The interfacing members 22 and 24 shown in FIG. 2 are examples ofclasps that grab and hold medicine containers by either squeezingtightly around the perimeter of the vial or by adhering to the surfaceof the vial; however, multiple interfacing members may be of other formsas well.

Rather than having multiple interfacing members for holding containersof various sizes, a single adjustable interfacing member may be used.For example, the interfacing member could be a spiral shaped arm ofplastic or memory alloy that may flex to accommodate containers ofvarious sizes. Alternatively or additionally, a ratcheting zip tie orratchet tie can be used to bind vials of various sizes.

Ampules are containers of medication that may be broken open.Accordingly, after having been opened, ampules may have a sharp end ofbroken glass. Exemplary embodiments of the present invention may matewith open ampules in such a way as to protect the medical practitionerfrom risk of accidental contact with the sharp end of open ampules. FIG.3 illustrates a syringe capable of mating with a medicine container, forexample, an ampule 30 with a sharp end, while protecting the medicalpractitioner from risk of accidental contact with the sharp end,according to an exemplary embodiment of the present invention. As seenin FIG. 3, the syringe has a clamping unit 18 as an interfacing member.The clamping unit 18 may conceal the sharp end of the ampule 30 after itis snapped in place.

According to another exemplary embodiment of the present inventionillustrated in FIG. 4, the syringe 10 may include an adhesive cup 40 asan interfacing member. The adhesive cup 40 may have a concave surface toreceive the container. The adhesive cup 40 may be flexible to allow fora tail end of the adhesive cup to wrap around the vial for additionaladhesive contact.

A sterile packaging may cover the bonding adhesive to facilitate rapidbonding of the vial to the syringe, since removing the wrapperautomatically exposes the adhesive. Quick labeling may then be performedwith little to no opportunity for labeling error as the vial travelsfrom the hand that held it while medication was being drawn up directlyto the adhesive pad.

The adhesive cup 40 may be made of a soft plastic and/or foam orotherwise deformable material and may be able to bond to vials ofdifferent diameters by accommodating a desired radius of curvature. Theadhesive cup may be mounted on an extension that protrudes from thesyringe or the adhesive cup may be mounted directly to the syringe.

Alternatively, the adhesive cup 40 may be rigid. The adhesive cup 40 maycomprise a contoured arm covered by adhesive glue for mating with thecontainer. The adhesive cup 40 may be strongly adhesive to preventremoval of the container or may be less-strongly adhesive to allow forremoval and replacement of the container.

Alternatively, a removably adhesive device, for example, VELCRO fabrichook-and-loop fastener strips, may be provided on the adhesive cup 40.For example, a first VELCRO fabric hook-and-loop fastener strip may beprovided upon the adhesive cup 40 and a second VELCRO fabrichook-and-loop fastener strip that is capable of mating with the firstVELCRO fabric hook-and-loop fastener strip may be provided, in a matedstate, upon the first VELCRO fabric hook-and-loop fastener strip. Thesecond VELCRO fabric hook-and-loop fastener strip may then have anadhesive surface for mating with the container. Accordingly, a containermated with the adhesive surface may be freely removable from theadhesive cup 40 and replaceable by virtue of the VELCRO fabrichook-and-loop fastener strip. Alternatively, the first VELCRO fabrichook-and-loop fastener strip may be provided directly on the body of thesyringe instead of on the adhesive cup 40.

In such embodiments, VELCRO fabric hook-and-loop fastener is mentionedas an example of a suitable reatachable fastener, however, other matingfasteners such as snaps and magnetic devices may be used.

The adhesive surface of the adhesive cup 40 or second VELCRO fabrichook-and-loop fastener strip may be covered by a protective film toprotect the adhesive surface when contained in its sterile packaging.The concave surface may have an irregular concavity to allow for theholding of different sized containers, for example, a large ampule 30 aor a small ampule 30 b. For example, the concavity may have a largeradius at one end and have a small radius at the other end. Flexibilitymay also facilitate the holding of different sized containers.

For exemplary embodiments having an adhesive surface, either directly onthe adhesive cup 40 or on a second VELCRO fabric hook-and-loop fastenerstrip, the protective film that protects the adhesive surface may becoupled to the sterile packaging of the syringe such that when thesterile packaging is removed, so too is the protective film. Forexample, the protective film may be attached to the sterile packagingor, for example, the sterile packaging may itself protect the adhesivesurface. FIG. 5 illustrates a syringe capable of mating with a medicinecontainer according to an exemplary embodiment of the present invention.In FIG. 5, the syringe is packaged in a sterile packaging 50. Thesterile packaging 50 may be, for example, a two-layer peel packincluding an upper layer 50 a and a lower layer 50 b. The upper layer 50a may be transparent; the lower layer 50 b may be shrink-wrapped aroundthe flanges 55 of the syringe 10. The syringe 10 may include an adhesivecup 40 with an adhesive top surface. A layer of the sterile packaging50, for example, the upper layer 50 a may be pressed against theadhesive top surface of the adhesive cup 40.

When opening the sterile packaging 50, the medical practitioner may gripthe syringe 10 in the sterile packaging 50 in the vicinity of theflanges 55 and a hook-end 57 while a needle-end 52 of the syringe 10 isunpackaged. The medication may then be drawn from a vial prior tounpackaging the remainder of the syringe 10. When the remainder of thesyringe 10 is unpackaged, the upper layer 50 a may be pulled from theadhesive cup 40 thus exposing the adhesive top surface. The vial ofmedication used to fill the syringe may then be adhered to the adhesivecup 40, for example, in the manner discussed above. As discussed above,the adhesive cup 40 may utilize a permanent adhesive for irremovablyattaching the vial to the adhesive cup 40 or a milder adhesive may beused for removably attaching the vial to the adhesive cup 40.Embodiments allowing for removal may incorporate the use of a tether formaintaining a link between the vial and the syringe even when the vialis in a removed state.

The syringe 10 illustrated in FIG. 5 may be used in a different way.When opening the sterile packaging 50, the medical practitioner may gripthe syringe 10 in the sterile packaging 50 in the vicinity of theflanges 55 and a hook-end 57 while a needle-end 52 of the syringe 10 isunpackaged. The medication may then be drawn from a vial prior tounpackaging the remainder of the syringe 10. The now filled syringe maybe further unpacked and dropped onto a surgical sterile field. When usedin this way the time required to draw up medication into a sterilesyringe on a sterile surgical field may be decreased as compared to thetraditional method of pouring the medication into a sterile cup andhaving a scrub nurse draw the medication into the syringe. By extendinga long tether from the syringe off of the field and connecting it to thevial, the vial can still serve as the label. Alternatively, the vial canbe dropped into a sterile plastic bag, which may then be attached to thesyringe as previously described. Accordingly, the syringe may be filledprior to being placed on a sterile field without compromising itssterility. This feature may be implemented either separately from or inaddition to the features discussed herein relating to correctly labelingsyringes. In another alternative, the syringe can be packaged with asterile pen and labeled in the traditional way by writing the name ofthe mediation on the adhesive plate after the loaded, but still sterilesyringe is dropped out of the packaging and on to the sterile field.

The syringe 10 may also include an indicator pad 59 which may act as atimer to indicate the time which has elapsed since opening the packageor since filling the syringe. The act of tearing apart the peal packingcan act as a trigger which begins the process of timing. Furthermore,such a device can be used on all medical supplies which come in sterilepackaging and must be unpacked prior to use. The indicator pad 59 may beused to indicate whether the sterile packaging 50 has been opened and/orfor how long the packaging 50 has been opened. According to oneexemplary embodiment of the present invention, the indicator pad 59 iscapable of changing color when removed from the packaging 50. Forexample, the indicator pad 59 may include a color-change dye thatchanges from one color to another color when exposed to ambient airand/or ambient light. For example, the color-change dye may change colorto reflect oxidation as the dye is exposed to oxygen in the atmosphere.In such a case, the sterile packaging 50 may be packaged in anoxygen-free environment, such as a vacuum or an environment filled withan inert gas such as nitrogen.

Alternatively, the color-change dye may change color when exposed toambient light. In such a case, an opaque covering may conceal theindicator pad 59 while the syringe 10 is packaged. When the syringe 10is removed from the wrapper, the opaque covering may be simultaneouslyremoved. For example, the opaque covering may be part of or otherwisecoupled to the packaging 50. The opaque covering may also be, or mayalternatively be a gas-impermeable protective covering that protects theindicator pad 59 from exposure to the air within the packaging 50. Thismay allow the syringe to be packed in an oxygen environment withoutinitiating color change in the indicator pad 59.

The indicator pad may include a chamber of disappearing ink or a similarsubstance which may be opened when the syringe is unwrapped, forexample, by ripping the ink's container and allowing it to stain a pieceof blotter paper. Photochrome ink, which disappears after 24 hours, canbe used for this purpose. When the blotter paper is clear, the syringehas been opened for more than 24 hours and should not be used. Thesetypes of timing devices can work through photochemical mechanisms, suchas previously described, or through a mechanical and/or electronicdevice. For example, opening the package may free up a spring in theside of the syringe which acts as a mainspring to start a disposablewatch.

In another example, the syringe can have thin coatings of differentlycharged materials separated by a thin insulator but connected to anelectrochemical watch by wires. Pulling apart the materials may thencause a momentary current flow which is enough to start theelectrochemical watch. Alternatively, other methods for implementing atimer that either counts the time that has elapsed since the package hasbeen opened and/or counts down the time for which the syringe remainsviable may be used. Such other methods as not herein disclosed may beunderstood by those of ordinary skill in the art, and are presumed to bewithin the scope of the exemplary embodiments of the present invention.

Alternatively the act of filling the syringe may initiate a timermethod, for example, it may cause a region of the syringe to begin tofill with the syringe contents, for example by a capillary action, whichmay then lead to a visible change in the syringe after a set amount oftime.

In yet another example of timing how long a syringe has been open, eachsyringe may be manufactured with a unique machine-readable indicatorsuch as a bar coded serial number. In environments where bar codescanning is used to confirm medication identity from the vial's barcode, the syringe number can be scanned as well and a computer can keeptrack of the time when any syringe was filled and what medicationactually entered the syringe. If problems occur, they may be trackedback to the lot of the drug and to the syringe itself.

The indicator pad 59 may have a single color change state that isinitiated during a single exposure to ambient conditions. In such acase, the indicator pad 59 indicates whether the packaging has beenopened. Alternatively, the indicator pad 59 may have multiple colorchange states, or may otherwise continuously change as ambient exposureincreases. In such a case, the length of time the syringe 10 has beenunpackaged for may be readily determined by examining the state of theindicator pad 59.

The indicator pad 59 may change color in a single section or may includemultiple sections that change color at different exposure durations.Each section may be a geometric shape or may form lettering and/ornumbering that helps to communicate the state of the indicator pad 59.Additional lettering and instructions may be printed on the syringe 10to help the user interpret the color change.

FIG. 6 shows a syringe 10 attached to a vial 14 via a locking member 60according to an exemplary embodiment of the present invention. Thelocking member includes an upper-portion 60 a that may be attached tothe vial, for example, by an adhesive, and a lower-portion 60 b that maybe attached to the syringe. The upper-portion 60 a and the lower portion60 b removably interlock, for example, by snapping, adhesiveness and/orby magnetic members. A tether 20 may connect the syringe 10 and the vial14 even when the vial 14 is detached. The tether 20 may be connected, atone end, either to the syringe 10 or to the lower-portion 60 b of thelocking member 60. The tether 20 may be connected, at the other end, tothe upper-portion 60 a of the locking member 60. By connecting thetether 20 to the upper-portion 60 a, the medical practitioner does nothave to affix the tether 20 to the vial 14. The tether 20 may be longenough to allow the needle 52 to be inserted into the vial 14 duringfilling. In some embodiments of the device the tether itself may be thetransfer tube by which the medication fills the syringe, while in othersthe tether is separate form the filling tube.

According to an exemplary embodiment of the present invention shown inFIG. 7, the tether 20 may include a band that connects to the syringe 10at one end and terminates in a loop 75 at the other end. The loop 75 mayclose upon the container 30, for example, by including a zip-tie. Theloop 75 may be adjustable to accommodate containers 30 of various sizes,for example, a small container 30 b or a large container 30 a. Theinterfacing member may be a fastening loop 70 that may either adhere tothe container 30 and/or lock around the container 30. The fastening loopmay be flexible and may thus accommodate containers of various sizes.

The syringe may also be configured to count the number of vials thathave been attached and then removed. This may be accomplished, forexample, by utilizing a multi-layered adhesive surface on the adhesivecup such that every time a vial is removed from the adhesive cup, thevial takes with it one of the adhesive layers. The number of vialsremoved from the syringe may then be determined from the number oflayers that have been removed from the adhesive cup. Each layer may benumbered such that the number clearly indicates to the medicalpractitioner how many layers have been removed, and thus, how many vialshave been attached to the adhesive cup. To prevent more than one suchlayer from being removed with a single vial, the various layers may beadhered to differing degrees or another method known in the art may beused. This feature may be especially useful where multiple vials ofmedication are used with a single syringe.

Exemplary embodiments of the present invention may utilize any number ofinterfacing members. FIG. 8 shows a syringe including multipleinterfacing members according to an exemplary embodiment of the presentinvention. As shown in FIG. 8, the syringe 10 may include multipleinterfacing members 80 a, 80 b, and 80 c of differing sizes so thatvariously sized containers may be properly accommodated. The interfacingmembers 80 a, 80 b, and 80 c may each rotate so that the unusedinterfacing members may be rotated so as not to obstruct the placementof the vial. Each of the interfacing members shown in this figure arehorseshoe shaped and at least somewhat flexible to allow for acylindrical vial to snap into place; however, other designs arepossible. The interfacing members 80 a, 80 b, and 80 c are each attachedto corresponding rings 81 a, 81 b, and 81 c and are thus free to rotateabout the syringe 10 shaft.

As shown in FIG. 8, the interfacing members may be formed of parts thatare added to the syringe apparatus during assembly. Alternatively, theinterfacing members may be manufactured as part of the syringe. FIG. 9shows a syringe with integrated interfacing members according to anexemplary embodiment of the present invention. In FIG. 9, theinterfacing members include a first interfacing member 92 and a secondinterfacing member 94 that are each formed as part of the syringe 10flange 90. Each interfacing member 92 and 94 are shown as beinghorseshoe shaped, however other configurations are contemplated. Twointerfacing members are shown, however, there may be any number ofinterfacing members, for example, there may be one, two, three, or fourinterfacing members. Each of the interfacing members may be configuredto accommodate a container 30 of a different size. For example,interfacing member 92 may accommodate a smaller container whileinterfacing member 94 may accommodate a larger container.

FIG. 10 illustrates a syringe including an interfacing member for matinga container of medication where the interfacing member includes amagnifying member for magnifying a label of the container of medicationaccording to an exemplary embodiment of the present invention. Here, thesyringe 10 may include an interfacing member 95, for example, asdescribed above. However, the interfacing member 95 may additionallyinclude a magnifying member 98, which may be, for example, a lens. Themagnifying member 98 may magnify text of the container label and thusmay make the contents of the container more easily read by the medicalpractitioner.

FIG. 11A illustrates a method for labeling a syringe according to anexemplary embodiment of the present invention. Where the syringe ispackaged in a sterile packaging as described above and illustrated inFIG. 5, the syringe may be removed from the sterile packaging (StepS1101). As described above, as the packaging is removed, an adhesivesurface of an interfacing member, for example, an adhesive cup, maybecome exposed. A hypodermic needle attached to the syringe may beinserted into a labeled container of medication and medication may bedrawn into the syringe (Step S1102). The needle may then be removed fromthe container (Step S1103) and the container may be mated to theinterfacing member (Step S1104). The interfacing of the container to theinterfacing member may include, for example, attaching the container tothe adhesive cup, where the interfacing member is an adhesive cup.

Alternatively, it is to be understood that the interfacing member mayalternatively include a configuration of any of the previously describedembodiments to retain the container and that steps S1101 and S1104 ofFIG. 11A may be substituted with steps S1201 and S1204 of FIG. 11B insome embodiments so that the method proceeds as illustrated in FIG. 11Bwith steps S1202 and S1203 of FIG. 11B corresponding to steps S1102 andS1103 of FIG. 11A. The interfacing member may remain mated to thesyringe when the syringe is in use. The interfacing member maynon-detachably mate with the container such that the container may notbe easily removed after mating. Alternatively, the interfacing membermay detachably mate with the container such that the container may beremoved and reattached, for example, when additional medication is to bedrawn up. In such cases, a tether may be used to retain a connectionbetween the syringe and the container, even when the container isdetached. The container may be mated to the interfacing member such thatthe label of the container is visible and the contents of the syringeare readily identifiable from the label.

According to another exemplary embodiment of the present invention, themethod of use follows the sequence shown in FIG. 11C. First, the desiredmedication is selected (Step S1301). Then, the vial may be connected tothe syringe (Step S1302). Then, the medication may be transferred fromthe vial to the syringe while the vial is in a connected state (StepS1303). Medication may then be injected (Step S1304).

Accordingly, when one or more of the exemplary embodiments areperformed, the syringe may be labeled independently of practitionerinput.

According to exemplary embodiments of the present invention, theinterfacing member may be a casing or bag member attached to thesyringe. The casing or bag member may be either flexible or rigid andmay contain a closing means such as a cap, draw string, twist tie,and/or zip lock. The casing or bag member may be transparent or may haveat least a transparent window. Thus, a medication container may beplaced in the casing or bag member when not in use, and a label of thecontainer may be seen through the casing or bag member.

Exemplary embodiments of the present invention may allow for thecommunication of medication from the container to the syringe while thecontainer is mated to the syringe. Such exemplary embodiments maytherefore minimize the risk of mislabeling by maintaining a mated stateof the container with the syringe, while allowing for simplified drawingof medication from the container to the syringe. FIG. 12 is a schematicillustrating a syringe capable of mating with a medicine container anddrawing medication from the container while in a mated state accordingto an exemplary embodiment of the present invention.

The syringe 10 may include a filling needle 120 and a needle-mount 121.The filling needle 120 may be inserted into the container 14. Thefilling needle 120 may include an air vent 122 for releasing air that isdrawn from the container 14 so that air is not drawn into the syringe10. The needle-mount 121 may include a one-way valve to prevent fluid inthe syringe 10 from reentering the container 14. The one-way valve mayinclude, for example, a spring and stopper arrangement as shown. Afilling hole 123 may be located on the tip of the filling needle 120 oralong the side of the filling needle 120 to facilitate the drawing ofmedication as the volume of medication in the container 14 becomes low.

According to some exemplary embodiments of the present invention, theone-way valve may be replaced with a mechanism for selectively cuttingoff the fluid connection between the filling needle and the syringe. Forexample, a switch may be used to close the fluid connection. The switchmay be implemented, for example, by rotating or folding down the fillingneedle, or by including a dam-like separator between the chamber of thesyringe 10 and the filling needle 120, which can be selectively openedor closed.

When the filling needle 120 is inserted into the container 14, thecontainer 14 may be clearly visible to allow for the label of thecontainer 14 to serve as a label for the syringe 10 and to clearlyidentify the contents of the syringe. The container 14 may be held inplace by the friction of the filling needle 120 within the container 14,or a receiving element (not shown) may be provided on the filling needle120 or needle-mount 121 to receive the cap 16 of the container 14 andprovide added support.

A medical practitioner, having inserted the filling needle 120 into thecontainer 14 may then draw medication from the container 14 via thefilling needle 120. To prevent air from being drawn into the syringe 10via the hypodermic needle 52, a one way valve may be incorporated intothe syringe 10 or hypodermic needle 52. Any air drawn from the container14 may be released from the air vent 122. Alternatively, a selectablevalve mechanism may be used to allow the medical practitioner to choosewhether medication is to be drawn from the filling needle 120 or thehypodermic needle 52.

Exemplary embodiments of the present invention may allow for fluidcommunication between the container and the syringe without relying onthe filling needle to hold the container in place. FIG. 13 is aschematic illustrating a syringe capable of mating with a container anddrawing medication from the container while in a mated state accordingto an exemplary embodiment of the present invention. Here, the container14 may be mated to the syringe 10, for example, by using one of thetechniques and/or apparatuses described above and illustrated in thefigures. For example, an adhesive cup 40, as described above, may beused as an interfacing member to mate the container 14 to the syringe10. A filling needle 131 may be provided at the end of a filling tube130. The filling tube 130 may be rigid or flexible, however, a flexiblefilling tube may more easily allow for the insertion of the fillingneedle 131 and the mating of the container 14 to the adhesive cup 40.The filling tube 130 may also serve as a tether as described above. Aone way valve (not shown) may be used for preventing medication frombeing pushed into the container 14 and an air vent (not shown) may beused to vent air drawn from the container 14).

As is seen in FIG. 12, exemplary embodiments of the present inventionincluding a filling needle 120 may provide the filling needle 120perpendicularly to the hypodermic needle 52. Alternatively, the fillingneedle 120 may be provided antiparallel to the hypodermic needle, asseen, for example, in FIG. 14.

FIG. 14 is a schematic illustrating a syringe capable of mating with amedicine container and drawing medication from the container while in amated state according to an exemplary embodiment of the presentinvention. Here, a filling needle 141 is provided antiparallel to thehypodermic needle 52. The filling needle may be attached to the plunger140 of the syringe 10, for example, such that fluid is communicatedthrough the plunger 140. As described above, a one-way valve 142 mayregulate the direction of flow though the filling needle 141 to ensurethat fluid can be drawn from the container 14 but cannot be pushed fromthe syringe 10 back into the container 14.

FIG. 18 is a syringe and penetration spike according to an exemplaryembodiment of the present invention. The syringe 10 includes a firstmale leur lock connector 11 for connecting with a female leur lock of ahypodermic needle. A penetration spike 53 with a female leur lock 2 mayalternatively be connected to the first male leur lock 11 of the syringe10. Accordingly, the penetration spike 53 may be used, for example,prior to the application of the hypodermic needle to facilitate thedrawing of medication from the vial 14. The penetration spike 53 may bemade of metal or a hard plastic and may have a sharp tip end. Thepenetration spike 53 may include a series of ridges 8 for allowing thevial 14 to be easily inserted while preventing the vial 14 from beingremoved from the penetration spike 53. Thus, after medication has beendrawn to the syringe 10 from the vial 14 through the spike 53, the spike53, attached to the vial, may be removed from the syringe 10.

The spike 53 so removed may then be reattached to the syringe 10, forexample, to a second male leur lock 4 that is positioned elsewhere onthe syringe. For example, the second leur lock 4 may be located on theside of the syringe 10, as shown, or alternatively on the back of thesyringe. Thus, the vial 14 may remain associated with the syringe 10including the medication so that the contents of the syringe 10 areclearly visible by virtue of the labeled vial.

According to some exemplary embodiments, the second male leur lock 4 mayfunction as a post for securing the spike 53 and may not allow for fluidexchange between the syringe 10 and the spike 53.

Either or both of the first male leur lock 11 and the second male leurlock 4 may be protected with a leur cap, for example, of the typediscussed above and illustrated in FIGS. 17a and 17b . Alternatively, atethered female leur cap may be used, particularly for the second maleleur lock 4.

The spike 53 may include separate paths for medication withdrawal 5 andair entry 6 to displace the volume of the drawn up medication.Alternatively the spike could be non-vented, possessing only the pathfor medication withdrawal 5. In the embodiment with the two paths 5 and6, drawn air entering the vent can pass through an anti-bacterial filter13 prior to entering the vial.

The spike 53 may additionally include handles 9 for facilitatinguntwisting of the spike 53 from the syringe's first mail leur 11 andre-attaching it to the second male leur 4.

After medication is drawn up, the syringe may be attached to either ahypodermic needle or directly to an IV using the male leur 11. Ifadditional medication needs to be drawn up, the syringe may be detachedfrom the hypodermic needle or the IV and the spike may be transferredfrom the second male leur 4 back to the first male leur 11.

FIG. 19 is a schematic diagram illustrating a syringe and penetrationspike apparatus according to an exemplary embodiment of the presentinvention. This exemplary embodiment is a variant of the embodimentdiscussed above with respect to FIG. 18, however; here, a conventionalsyringe may be used. Here, an adapter unit 190 has a lock 191 forattaching to the tip of a syringe. The adapter unit 190 also has a firstconnector 193 for connecting to a spike 53. The spike 53 may be similarto the spike described above with reference to FIG. 18. The adapter unit190 may also have a second connector 194 for connecting to a hypodermicneedle. In other exemplary embodiments, the adapter unit 190 may beintegrated with the syringe, in which case no lock 191 is needed.

The first connector may include a first valve 195 that permits fluid tobe drawn from the spike 53 to a body portion 197 of the adapter unit 190and to the syringe while preventing fluid from flowing back from thesyringe to the spike. The second connector 194 may include a secondvalve 196 that permits fluid to exit the syringe through the hypodermicneedle while preventing fluid from flowing back from the needle to thesyringe. Accordingly, the vial may remain attached to the spike whichmay remain attached to the syringe so that the contents of the syringemay be known. Moreover, additional medication may be easily drawnwithout having to remove the spike. In this embodiment, handles 9 may beomitted from the spike 53 as the spike need not be repeatedly removedand reattached. Additionally, the second connector 194 may attachdirectly to an IV where no hypodermic needle is desired.

As described above, the adapter unit 190 may be separate from thesyringe or may be integrated with the syringe. For example, the adapterunit 190 may be permanently attached to the syringe.

The above devices may be used as part of an intravenous anesthesiamachine and may be combined with a bar code scanner, as described above,to identify the medication in the vial. The intravenous anesthesiamachine may include an optical sensor for keeping track of the volume ofmedication injected. Alternatively, a video capture device may be usedto identify the contents of the vial by performing optical characterrecognition on the vial label or by pattern recognition system inaccordance with known methods for computer vision-based identification.Drug identification may also be confirmed verbally by means of acomputer program that speaks the name, concentration and starting volumeor total dose in the syringe prior to giving any medication.

Exemplary embodiments of the present invention may also provide for aspring-loaded needle sheath for covering the hypodermic needle when notin use. FIG. 15 is a schematic illustrating a spring-loaded needlesheath according to an exemplary embodiment of the present invention.Covering a hypodermic needle 52 allows for the syringe 10 to be placeddown without risk of contaminating the needle 52. Exemplary embodimentsof the present invention allow for the single-handed covering of thehypodermic needle in such a way that the practitioner would not have tohold the syringe in one hand and the separate cap in the other hand, andplace the cap on the needle, an action that may present an increasedrisk of puncture injury.

Accordingly, exemplary embodiments of the present invention endeavor tosheath the hypodermic needle without risk of accidental puncture.Accordingly, exemplary embodiments of the present invention provide fora needle sheath 150 that protects the hypodermic needle 52 when not inuse. The sheath 150 may have a cutout (not shown) that is larger thanthe needle so that the sheath may be easily pulled from and returned tothe needle 52 without obstruction. The sheath 150 may be connected to apivot 151 and may be spring-loaded with a spring 152. The configurationof sheath 150, pivot 151, and spring 152 are provided as an example andother arrangements are possible.

The sheath 150 may be arranged such that it tends to a closed positionin the absence of force. Accordingly, when the hypodermic needle 10 isput down or dropped, the sheath 150 quickly covers the needle such thatrisks of contamination and/or accidental puncture are reduced.

FIG. 16 is a flow chart illustrating a method for administering ahypodermic injection according to an exemplary embodiment of the presentinvention. First, force may be applied to the needle sheath to move, forexample, slide and/or rotate, the sheath around pivot 151 and reveal thehypodermic needle (Step S160). Then, while the needle is revealed, andwhile force continues to be applied, the hypodermic injection may beadministered (Step S161). Finally, after the injection has beenadministered, the force may be discontinued and the needle sheath mayreturn to its original position concealing the hypodermic needle (StepS162).

FIGS. 17a and 17b are schematics illustrating a luer tip syringe with aprotective cap according to an exemplary embodiment of the presentinvention. When a hypodermic needle is not attached to a syringe, asshown in the syringe of FIG. 17a and the syringe of FIG. 17b , thesyringe may have an exposed male luer tip 171. To protect the male luertip 171 from damage and to preserve its sterility, a spring-cap 172 maybe provided as part of the syringe. The spring-cap 172 may be openedwith a single press such that a practitioner may both handle the syringeand open the spring-cap 172 with a single hand. The spring-cap 172 maybe provided with a restoring force such that there is an inclination forthe spring cap 172 to close around the male luer tip 171 when an openingforce is not applied. The restoring force may be provided with a springor another restoring device such as an elastic member or a memory foam.

Exemplary embodiments of the present invention may substantially reduceor virtually eliminate the risk of mislabeling syringes that are filledwith various medications. Accordingly, medication may be more safelyadministered to patients, for example, in an operating room setting.Therefore, the potential for complications resulting from administrationof incorrect medication may be reduced and patient safety mayaccordingly be improved.

The above specific exemplary embodiments are illustrative, and manyvariations can be introduced on these embodiments without departing fromthe spirit of the disclosure or from the scope of the appended claims.For example, elements and/or features of different exemplary embodimentsmay be combined with each other and/or substituted for each other withinthe scope of this disclosure and appended claims.

What is claimed is:
 1. A system comprising: a penetrating spike; and asyringe; wherein the penetrating spike is adapted for attachment to thesyringe; wherein the penetrating spike comprises: a body unit that atone end is adapted to be inserted into a vial; and an adapter unit forconnecting the body unit to the syringe; wherein the adapter unit islocated at a second end of the body unit opposite to the one end that isadapted to be inserted into the vial; wherein the body unit contains oneor more ridges for preventing the body unit from being removed from thevial; and wherein the entirety of the syringe extends between a top endand a bottom end opposite the top end and comprises: a first adapterunit at the bottom end for mating with the adapter unit of thepenetrating spike; and a second adapter unit adjacent the top end formating with the adapter unit of the penetrating spike, wherein thesecond adapter unit does not allow for fluid exchange between thesyringe and the penetrating spike.
 2. The system of claim 1, wherein thefirst and second adapter units each comprise luer connectors.
 3. Thesystem of claim 2, wherein at least one of the luer connectors comprisesa cap covering the at least one of the luer connectors.
 4. The system ofclaim 3, wherein the cap is biased in a position covering the at leastone of the luer connectors.
 5. The system of claim 1, wherein thepenetrating spike further comprises one or more handles for facilitatingremoval or placement of the penetrating spike from or to the syringe. 6.The system of claim 1, wherein the body unit includes a first pathwayfor passing fluid from the vial to the syringe and a second pathway forallowing air to enter the vial as the fluid is removed.
 7. The system ofclaim 1, wherein: the syringe comprises a cylindrical body having aheight extending between the top end to the bottom end; and the secondadapter unit is positioned on a surface of the cylindrical body.
 8. Thesystem of claim 7, wherein the second adapter unit contacts the surfaceof the cylindrical body.
 9. The system of claim 1, wherein the one ormore ridges comprise a plurality of ridges in a stacked configuration.10. A system comprising: a penetrating spike; and a syringe; wherein thepenetrating spike is adapted for attachment to the syringe; wherein thepenetrating spike comprises: a body unit that at one end is adapted tobe inserted into a vial; and an adapter unit for connecting the bodyunit to the syringe; wherein the adapter unit is located at a second endof the body unit opposite to the one end that is adapted to be insertedinto the vial; wherein the body unit contains one or more ridges forpreventing the body unit from being removed from the vial; and whereinthe entirety of the syringe extends between a top end and a bottom endand comprises: a first adapter unit for mating with the adapter unit ofthe penetrating spike, wherein the first adapter unit is located at thebottom end of the syringe; a second adapter unit spaced apart from thefirst adapter unit for mating with the adapter unit of the penetratingspike; and a cylindrical body having a height extending in a directionfrom the top end to the bottom end; wherein the second adapter unit ispositioned on a surface of the cylindrical body adjacent the top end;and wherein the second adapter unit does not allow for fluid exchangebetween the syringe and the penetrating spike.
 11. The system of claim10, wherein the second adapter unit contacts the surface of thecylindrical body.
 12. The system of claim 10, wherein the one or moreridges comprise a plurality of ridges in a stacked configuration.